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NCT01156376 · ClinicalTrials.gov registry record · NA
Oral Irritation Study of Two Experimental Mouthrinses
A NA study of Oral Manifestations, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT01156376: Completed NA study of Oral Manifestations, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
NCT01156376 is a NA study of Oral Manifestations that has completed, run by Johnson & Johnson Consumer and Personal Products Worldwide. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01156376, a NA study of Oral Manifestations, has completed, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the study, people will continue to brush two times a day and will return on Day 24 to have their mouth looked at again. People without irritation in their mouth will rinse 4 times a day at the clinical site. People will return to the clinical site the next day and have a final oral exam in which the dentist or dental hygienist will look at the mouth for irritation.
Primary Outcome
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.
Conditions Studied
Interventions
- DEVICE Potassium Oxalate without Fluoride
- DEVICE Potassium Oxalate with Fluoride
- DEVICE Active Comparator PO-116-A
Study Locations (1)
Indiana
- University Park Research Center (UPRC) - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-07 |
| Phase | NA |
What the finished NCT01156376 record still lists
NCT01156376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Oral Manifestations appearing as the primary indexed condition, and to 3 interventions - of which Potassium Oxalate without Fluoride is the first listed.
NCT01156376 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT01156376 about?
NCT01156376 is a clinical study titled "Oral Irritation Study of Two Experimental Mouthrinses". This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make su...
What is the current status of trial NCT01156376?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2010-06. Estimated completion is 2010-07.
What conditions does trial NCT01156376 study?
This clinical trial studies the following conditions: Oral Manifestations.
What interventions are being tested in trial NCT01156376?
The interventions under investigation include: Potassium Oxalate without Fluoride (DEVICE), Potassium Oxalate with Fluoride (DEVICE), Active Comparator PO-116-A (DEVICE).
Who is sponsoring clinical trial NCT01156376?
This trial is sponsored by Johnson & Johnson Consumer and Personal Products Worldwide, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01156376 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01156376's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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